The following data is part of a premarket notification filed by Us Medical Innovations Llc with the FDA for Canady Plasma Electrosurgical Unit Series With Accessory Probes And Blades.
Device ID | K100669 |
510k Number | K100669 |
Device Name: | CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | US MEDICAL INNOVATIONS LLC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
Contact | Krista Oakes |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-03-09 |
Decision Date | 2011-04-06 |
Summary: | summary |